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DNA influenza vaccine safe, immunogenic in children
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BETHESDA, Md. — A DNA-based influenza vaccine regimen was safe and well tolerated in children and adolescents and evoked higher immune responses compared with a trivalent inactivated vaccine regimen, according to preliminary data presented at the 2014 Annual Conference on Vaccine Research.
The multicenter study was the first to investigate a pediatric DNA vaccine in the United States.
Julie E. Ledgerwood, DO, chief of the clinical trials program at the NIH’s Vaccine Research Center, and colleagues assessed the safety and immunogenicity of a hemagglutinin (HA) DNA vaccine prime followed by a TIV boost in children and adolescents aged 6 to 17 years (52% male) in five sites. Participants received either the HA DNA vaccine at 1 mg (n=12) or 4 mg (n=32), followed 18 weeks later by a matched 2012-2013 seasonal TIV. A comparator group of 31 participants received a TIV-TIV prime-boost regimen at similar intervals. The strains included in the study were A/California/04/2009 (H1N1), A/Victoria/361/2011 (H3N2) and B/Wisconsin/1/2010.
Julie Ledgerwood
All study participants completed both vaccinations.
According to the researchers, all of the regimens were well tolerated. Ledgerwood said the delivery system for DNA vaccines tend to be more painful than that of other vaccines. Participants more frequently reported pain/tenderness, redness or swelling after HA DNA vaccination compared with TIV (P<.001 for all comparisons), but the majority had only mild complaints.
The researchers also found that children prepped with the 4 mg HA DNA vaccine demonstrated greater frequency (P=.026) and magnitude (P=.003) of hemagglutination-inhibition (HAI) antibody responses for the B/Wisconsin/1/2010 vaccine strain at 4 weeks post-boost than children who received the TIV-TIV prime-boost regimen.
“This was a little bit of a pleasant surprise because the B antigen is oftentimes poorly immunogenic, especially in children” Ledgerwood said during her presentation.
The 4 mg DNA vaccine group also had a 13.68-fold (95% CI, 7.32-25.57) increase in magnitude of HAI responses to the A/California/04/2009 (H1N1) strain at 4 weeks post-boost vs. a 4.09-fold increase (95% CI, 2.53-6.61) in magnitude among children who received the TIV prime (P=.003)
“As far as we know, this was the first DNA vaccine study in healthy children in the US,” Ledgerwood said. “It was safe and well tolerated, and the 4 mg DNA prime group had statistically improved responses by frequency and/or magnitude for two of the three vaccine strains.”
Ledgerwood added that the DNA vaccine group’s response to the influenza B strain warrants further study.
For more information:
Ledgerwood J. E. Abstract #S1. Presented at: Annual Conference on Vaccine Research; April 28-30, 2014; Bethesda, Md.
Disclosure: Ledgerwood reports no relevant financial disclosures.